Actively Recruiting

Age: 60Years - 80Years
All Genders
ID06933108

Estimate the Risk of Diabetic and Uremic Peripheral Neuropathy Using Physical and Functional Testing

Led by Université catholique de l'Ouest · Updated on 2025-04-18

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

Université catholique de l'Ouest

Lead Sponsor

C

Centre Hospitalier le Mans

Collaborating Sponsor

AI-Summary

What this Trial Is About

Diabetes and chronic kidney disease (CKD) are separate health conditions that both frequently lead to peripheral neuropathy, a nerve disorder causing pain and reduced muscle strength. This research focuses on using physical and balance tests during regular care to predict the risk of peripheral neuropathy in people aged 60 to 80 with diabetes or CKD. The study aims to improve early and reliable detection, as current clinical and laboratory tests have limitations and inconsistencies. This observational study does not involve drug treatments but evaluates participants through functional testing that measures balance and physical abilities. These assessments include analyzing postural balance using stabilometric methods and measuring the time a person can balance on one leg. By combining these functional measures, researchers hope to create a composite score that can predict peripheral neuropathy risk more accurately than existing tests. Participants will undergo these balance and physical tests as part of routine care in adapted physical activity settings. Researchers will collect data at baseline to develop a statistical model for the composite score. This approach aims to provide an objective, early marker of neuropathic impairment. The study will monitor participants' functional capacities without intervention, and participation is expected to last for the duration of the study period starting in early 2025.

CONDITIONS

Brief Title

Prediction of Peripheral Neuropathy With Functional Testing

Who Can Participate

Age: 60Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have stage 4 or 5 chronic kidney disease and/or type 1 or type 2 diabetes
  • Able to walk 20 meters
  • Body mass index (BMI) less than 35
  • Aged between 60 and 80 years old
Not Eligible

You will not qualify if you...

  • Currently undergoing or planning to start dialysis treatment
  • Have musculoskeletal, joint, or neurological diseases
  • Have cognitive impairment
  • Have had a lower limb amputation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At baseline

Participants undergo physical and functional testing to assess risk of peripheral neuropathy.

1 visit (in-person)

Long-term Monitoring

Duration - Up to study completion in May 2025

Participants are observed over time to monitor progression of peripheral neuropathy risk.

Visits as scheduled by the study team

Trial Site Locations

Total: 1 location

1

Centre Hospitalier Le Mans

Le Mans, France, 72000

Actively Recruiting

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Research Team

G

Giorgina Barbara Piccoli, Professor, Medical Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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